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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINTRAOCULAR LENS MODELS C118;C119;C138 AND C139
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP880010
Supplement NumberS003
Date Received11/04/1988
Decision Date08/17/1989
Withdrawal Date06/23/2010
Product Code HQL 
Docket Number 89M-0357
Notice Date 04/05/1990
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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